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Home»Posts tagged with»FDA NDA

Will pediatric KONFIDENT-KID data accelerate KalVista’s sebetralstat approval in hereditary angioedema?

By Pallavi Madhiraju on March 21, 2026   Pharma & Biotech  

Will pediatric KONFIDENT-KID data accelerate KalVista’s sebetralstat approval in hereditary angioedema?

KalVista’s sebetralstat pediatric trial data heads to Madrid. What it means for the HAE on-demand market and a 2026 FDA filing. Read the analysis.

Why Deciphera Pharmaceuticals’ tirabrutinib NDA matters for the future of CNS lymphoma therapy

By Pallavi Madhiraju on February 18, 2026   Pharma & Biotech  

Why Deciphera Pharmaceuticals’ tirabrutinib NDA matters for the future of CNS lymphoma therapy

FDA accepts tirabrutinib NDA for relapsed or refractory PCNSL. Find out what this means for CNS lymphoma treatment and regulatory strategy.

FDA accepts pimicotinib NDA for TGCT: What this signals for rare tumor drug development and the CSF-1R inhibitor class

By Pallavi Madhiraju on January 13, 2026   Pharma & Biotech  

FDA accepts pimicotinib NDA for TGCT: What this signals for rare tumor drug development and the CSF-1R inhibitor class

Find out how Abbisko’s TGCT drug pimicotinib just crossed a major milestone with the FDA—and what this means for patients and the CSF-1R class.

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